NA 176

DIN Standards Committee Health Technologies

Project

Elastomeric parts for parenterals and for devices for pharmaceutical use - Part 5: Functional requirements and testing (ISO/DIS 8871-5:2024); German and English version prEN ISO 8871-5:2024

Abstract

ISO 8871-5:2016 specifies requirements and test methods for functional parameters of elastomeric closures used in combination with vials and when pierced by an injection needle. NOTE Functional testing with spikes is specified in ISO 8536‑2 and in ISO 8536‑6.

Begin

2022-11-03

WI

00205391

Planned document number

DIN EN ISO 8871-5

Project number

06302178

Responsible national committee

NA 176-04-05 AA - Elastomeric pharmaceutical packaging and related components  

Responsible european committee

CEN/TC 205 - Non-active medical devices  

Responsible international committee

ISO/TC 76/WG 4 - Elastomeric parts and components and related secondary packaging components  

draft standard

Elastomeric parts for parenterals and for devices for pharmaceutical use - Part 5: Functional requirements and testing (ISO/DIS 8871-5:2024); German and English version prEN ISO 8871-5:2024
2024-05
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previous edition(s)

Elastomeric parts for parenterals and for devices for pharmaceutical use - Part 5: Functional requirements and testing (ISO 8871-5:2016); German version EN ISO 8871-5:2016
2017-03

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Contact

Dipl.-Ing.

Margarethe Boresch

Am DIN-Platz, Burggrafenstr. 6
10787 Berlin

Tel.: +49 30 2601-2413
Fax: +49 30 2601-42413

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